FTC Set To Take Enforcement Action Against Drugmakers Over Orange Book Patent Listings
Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.
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In Swift Challenge To Orange Book Patent Listings, Federal Trade Commission Fills FDA Ministerial Gap
Agency sends letters to 10 companies saying they improperly listed patents in US FDA’s Orange Book covering drug-device combination products. FTC does not specify why it believes the patents were improperly listed.
Commission pursued merger challenge to halt pharma practices it believes can stifle competition and keep drug prices high. Other large biopharma transactions may face similar challenges as FTC pursues its new merger program.
Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.